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关于食蟹猴体内药动学研究中英翻译文件 |
3. 摘要 Abstract
3.1食蟹猴体内药动学研究 In vivo pharmacokinetic studies on cynomolgis monkeys
研究了rhGH-I单次s.c 50、150和500 ug?kg-1、多次s.c 50 ug?kg-1/d?4（每天给药一次，连续4天）、i.v 150 ug?kg-1的药代动力学并与s.c 150 ug?kg-1 rhGH-I比较。
We studied the pharmacokinetics of single rhGH-I s.c 50, 150 and 500 ug?kg-1, multiple s.c 50 ug?kg-1/d?4 (once a day for continuous 4 days) and i.v 150 ug?kg-1, and compared the pharmacokinetics of i.v 150 ug?kg-1 and s.c 150 ug?kg-1 rhGH-I.
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单次s.c 50、150和500 ug?kg-1后Tmax为3～5 h，Cmax分别为53.01±2.74、167.93±11.57和553.79±28.99 ng/ml。末端半衰期分别是2.67±0.11、2.56±0.24和2.92±0.25 h, 各组之间无统计学意义上的显著性差异(p﹥0.05); MRT分别为5.39±0.11、5.43±0.35和5.37±0.07 h。AUC（0-∞）分别为411.07±18.69、1254.75±169.57和3785.56±417.64 ng.h.ml-1，比值为1：3.05：9.16。平均清除率分别为0.12±0.01、0.12±0.02和0.13±0.01 mL?kg-1?h-1，各剂量间没有统计学差异，不随剂量变化而变化, 基本表现为线性药代动力学特征。s.c 150 ug?kg-1组的绝对生物利用度为88.22%。相对rhGH的生物利用度为109.50%。
Tmax after s.c 50, 150 and 500 ug?kg-1 were among 3～5h and Cmax were 53.01±2.74, 167.93 ± 11.57 and 553.79±28.99 ng/ml, respectively. Terminal half lives were 2.67±0.11, 2.56 ± 0.24 and 2.92±0.25 h respectively and the differences between each two group were of no statistical significance (p﹥0.05). MRT were 5.39±0.11, 5.43±0.35 and 5.37 ± 0.07h, respectively. AUC(0-∞) were 411.07±18.69, 1254.75 ± 169.57 and 3785.56±417.64 ng.h.ml-1 and the ratio is 1:3.05:9.16. The average clearance rates were 12 ± 0.01, 0.12 ± 0.02 and 0.13±0.01 mL?kg-1?h-1 respectively and the differences among all dose groups had no statistical significance. The average clearance rates did not change with doses, basically showing linear pharmacokinetic characteristics. The absolute bioavailability of s.c 150 ug?kg-1 group was 88.22%. The relative rhGH bioavailability was 109.50%.
单次s.c 150 ug.kg-1 rhGH后， AUC（0-∞）为1145.90±200.84 ng.h.mL-1, 清除率为0.13±0.02 mL.kg-1.h-1, 末端半衰期为2.57±0.19 h, MRT为5.10±0.33 h, VSS为0.49±0.05 mL?kg-1。与rhGH-I在食蟹猴体内的药代动力学特点无明显差别。
After single dose of s.c 150 ug.kg-1 rhGH, AUC (0-∞) was 1145.90±200.84 ng.h.mL-1 and the clearance rate was 0.13±0.02 mL.kg-1.h-1. Terminal half life was 2.57±0.19 h. MRT was 5.10±0.33 h and VSS was 0.49±0.05 mL?kg-1. The pharmacokinetic characteristics showed no significant differences comparing with that of rhGH-I in cynomolgis monkeys.
连续4次s.c 100 ug?kg-1后峰、谷浓度均无明显变化，末次和首次给药后各药代参数无明显变化，蓄积因子为0.98?0.08。
After 4 continuous s.c 100 ug?kg-1, both the peak and the valley concentrations showed no significant changes, neither the pharmacokinetic parameters after the first and last administration. The accumulation factor was 0.98?0.08.
i.v 150 ug.kg-1后Cmax为1049.89±105.28 ng/ml，末端半衰期为2.64±0.17 h，MRT为3.28±0.03 h。AUC（0-∞）是1422.22±17.05 ug?h?mL-1。平均清除率为0.11±0.00 mL?kg-1?h-1，其主要参数除Cmax和MRT外，与s.c 150 ug.kg-1组比较均无统计学差异。
After i.v 150 ug.kg-1, Cmax was 1049.89±105.28 ng/ml. Terminal half life was 2.64±0.17 h. MRT was 3.28±0.03 h. AUC (0-∞) was 1422.22±17.05 ug?h?mL-1. The average clearance rate was 0.11±0.00 mL?kg-1?h-1. The main parameters except Cmax and MRT showed no statistical differences comparing with that of s.c 150 ug.kg-1 group.
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